For the Goodwin Biotechnology Biosimilars brochure, please click here or on the picture.

Biosimilars - A Quality by Design Concept

Biologicals are the fastest growing segment of the pharmaceutical market and over 30 branded biologics with sales in excess of $50 billion are facing patent expirations. That represents a significant business opportunity to develop Biosimilars.

However, the development of a Biosimilar is not without challenges. The complexity of the problem equates with the complexity of the molecule. Biosimilars can be expensive to manufacture, fully characterize in comparison with the innovative biomolecule, conduct the pharmacology and toxicology studies, then design and execute the requisite clinical trials. Unlike with small molecule generics, the process of developing and commercializing a Biosimilar can take upwards of 7 years or even longer.

When one develops an innovative protein, they can define their own criteria. However, when making a Biosimilar, the product and process developed have to meet much tighter regulatory standards. Biosimilar companies will need to provide a significant amount of analytical, physical and clinical evidence to demonstrate that it is highly similar to the innovator.

A number of biosimilars have been approved and launched in Europe. Despite the fact that the European Medicines Agency developed some general guidance in 2005, which is currently under revision, and has since released other guidelines for manufacturing requirements and analytical specifications for specific biological types, and the International Conference on Harmonization (ICH) published its Q6b quality guidelines that describe test procedures and acceptance criteria for biologics, the development of a biosimilar remains a hot topic of discussion.

Meanwhile, in the U.S., the 2009 Biologics Price Competition and Innovation Act (BPCIA) helped provide the industry with the legislative pathway to approval of Biosimilars, and the FDA published an article in 2011 that provided some insight into how those guidelines might actually play out. For the FDA Guidelines, please click here. In short, the FDA seems to implementing the concept of Quality by Design (QbD), which is a systematic and science-driven approach demanding the application of process understanding (process parameters and process controls) and product knowledge (product specifications and product quality attributes) to present a “totality of evidence” required to confirm sufficient similarity.